Cleared Traditional

K070688 - NEXFIX COMPRESSION STAPLE

K070688 is an FDA 510(k) clearance for NEXFIX COMPRESSION STAPLE, manufactured by Nexa Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K070688 · Nexa Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
67d
Days
Class 2
Risk

K070688 is an FDA 510(k) clearance for the NEXFIX COMPRESSION STAPLE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Nexa Orthopedics, Inc. (San Diego, US). The FDA issued a Cleared decision on May 18, 2007 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nexa Orthopedics, Inc. devices

FDA 510(k) Submission Details - K070688

510(k) Number K070688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date May 18, 2007
Days to Decision 67 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDR Staple, Fixation, Bone

All 149
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K070688.
BIOPRO MEMORY STAPLE, MODELS 18062-18073
K072298 · Biopro, Inc. · Oct 2007
SBI STAFIX
K071479 · Small Bone Innovations, Inc. · Aug 2007
MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD
K071257 · Depuy Mitek, A Johnson & Johnson Company · Jun 2007
ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
K061776 · Arthrotek, Inc. · Sep 2006
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · Depuy Mitek, A Johnson & Johnson Company · Aug 2006
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006